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Clinical Trials/NCT03413527
NCT03413527
Unknown
Phase 2

Examining the Impact of Transcranial Magnetic Stimulation (rTMS) on Schizophrenia and Related Disorders: A Case Series

St. Joseph's Healthcare Hamilton1 site in 1 country20 target enrollmentFebruary 2016
ConditionsSchizophrenia

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
20
Locations
1
Primary Endpoint
Positive and Negative Symptom Scale (PANSS)
Last Updated
7 years ago

Overview

Brief Summary

This study will examine the effects of rTMS on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
February 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gary Chaimowitz

Principal Investigator, Head of Forensics Service

St. Joseph's Healthcare Hamilton

Eligibility Criteria

Inclusion Criteria

  • are voluntary and competent to consent to treatment
  • have a diagnosis of schizophrenia or schizoaffective disorder
  • are between the ages of 18 and 75
  • are willing and able to adhere to the treatment schedule
  • Pass the TMS adult safety-screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized.
  • are willing and able to cooperate with interviews and follow simple instructions

Exclusion Criteria

  • do not pass the TASS Safety Screening Questionnaire
  • have a significant history of seizures
  • have active suicidal intent
  • are pregnant or may be pregnant. A pregnancy test will be performed for fertile women.
  • have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode
  • have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes
  • have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  • have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. Patients may be re-screened once medications have been stable for 4 weeks.
  • currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy

Outcomes

Primary Outcomes

Positive and Negative Symptom Scale (PANSS)

Time Frame: Change from pre-treatment to post treatment over 6 weeks

semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.

Secondary Outcomes

  • Hamilton Depression Rating Scale (HAM-D)(change from pre-treatment to post treatment over 6 weeks)
  • Beck Depression Inventory(Change from pre-treatment to post treatment over 6 weeks)

Study Sites (1)

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